Glufosfamide Versus 5-FU in Second Line Metastatic Pancreatic Cancer

  • STATUS
    Recruiting
  • End date
    Mar 15, 2023
  • participants needed
    480
  • sponsor
    Eleison Pharmaceuticals LLC.
Updated on 24 January 2022
cancer
fluorouracil
gemcitabine
metastatic pancreatic cancer

Summary

The study is designed to assess whether glufosfamide provides additional survival benefit as compared to bolus 5-FU in patients with metastatic pancreatic cancer who have already progressed or failed therapy on a gemcitabine based first line regimen.

Details
Condition Metastatic Pancreatic Adenocarcinoma
Treatment fluorouracil, Glufosfamide
Clinical Study IdentifierNCT01954992
SponsorEleison Pharmaceuticals LLC.
Last Modified on24 January 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

At least 18 years of age
Pancreatic adenocarcinoma proven either by histology (surgical biopsy) or cytology (CT- or endoscopic-guided)
Metastatic pancreatic cancer
Disease progression during or after treatment with gemcitabine (alone or in combination with other agents; at regular, not radiosensitizing, doses)
Measurable or nonmeasurable disease by RECIST criteria (at least one target or nontarget lesion)
Recovered from reversible toxicities of prior therapy
ECOG performance status 0-1
All women of childbearing potential and all men must agree to use effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) from entry into the study through 6 months after the last dose of chemotherapy
Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee

Exclusion Criteria

More than one prior systemic therapy regimen for metastatic pancreatic cancer (radiosensitizing doses of 5-FU or gemcitabine at the time of initial radiotherapy do not count as a prior systemic therapy regimen)
Hormonal therapy, radiation therapy, biologic therapy, chemotherapy or other systemic antitumor therapy for pancreatic cancer within 14 days prior to Cycle 1 Day 1
Insulin-dependent diabetes mellitus (patients with type 2 diabetes controlled with oral glucose lowering agents and the occasional use of insulin are permitted in the study)
Symptomatic brain metastases (baseline CT scan is not required in asymptomatic patients)
Active clinically significant infection requiring antibiotics
Known HIV positive or active hepatitis B or C
Recent (one year) history or symptoms of cardiovascular disease (NYHA Class 2, 3, or 4), particularly coronary artery disease, arrhythmias or conduction defects with risk of cardiovascular instability, uncontrolled hypertension, clinically significant pericardial effusion, or congestive heart failure
No other active malignancies (other than treated non-melanoma skin cancer or treated in situ cancer) within the past year
Major surgery within 3 weeks of the start of study treatment, without complete recovery
Clinically significant abnormalities in laboratory test results (including complete blood count, chemistry panel including electrolytes, and urinalysis)
Hemoglobin <9 g/dL (may receive transfusion or erythropoietin to maintain)
ANC <1500/L
Platelet count <100,000/L
Total bilirubin > 1.5ULN
AST/ALT > 2.5-fold above ULN (>5-fold above ULN if liver metastases)
Phosphorus < LLN
Potassium < LLN
Serum creatinine > 2 mg/dL
Creatinine clearance < 60 mL/min (calculated by Cockcroft-Gault formula)
Females who are pregnant or breast-feeding
Participation in an investigational drug or device study within 14 days of the first day of dosing on this study
Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the patient in this study
Any medical history, concurrent disease or concomitant medication which could reasonably predispose the patient to renal insufficiency while on study treatment
Contraindication or unwillingness to undergo multiple CT scans
Unwillingness or inability to comply with the study protocol for any other reason
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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